E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023350 |
E.1.2 | Term | Keratoconjunctivitis sicca |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Efficacy of Ialurex vs. Systane Eye Drops on the basis of the improvement of corneal fluorescein staining |
|
E.2.2 | Secondary objectives of the trial |
a) improvement of tear film stability b) improvement of ocular symptomatology |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria: Legally adult outpatients having given their written informed consent with : 1. Dry eye syndrome (either hyposecretive or hyperevaporative type) since at least two months. 2. Schirmer l test≤10 mm/5 min. 3. Positivity to vital corneal staining≥3/15 (NEI scheme). 4. Symptomatology of dry eye with at least two positive symptoms (VAS>60) in the preceding 72 hours, out of five: -burning/stinging sensation, -ocular discomfort while blinking -foreign body sensation -sensation of ocular fatigue/heaviness of the lid -willingness to keep eyes closed. 5. Willingness to participate in the study while following the indications |
|
E.4 | Principal exclusion criteria |
1. Age <18 years. 2. Pregnant or lactating women. 3. Women of childbearing potential who are not using adequate contraception methods. 4. Ocular surgery within the last three months. 5. Presence or onset of eye infections or of other acute pathologies which could be resolved or modified during the course of the study independently from the treatment with study drugs. 6. Presence or onset of glaucoma. 7. Using any topical ophthalmic medication with the exception of tear substitutes and/or eye cleaning solutions for the treatment of dry eye. 8. Patients being treated with topical ocular, cyclosporine, steroidal or non steroidal, anti-inflammatory medications within the last month. 9. Occlusion therapy with lachrymal or punctum plugs within the last 2 months. 10. Change in systemic treatment within the last 2 months. 11. Contact lens wearers. 12. Patients who have participated in any clinical investigation within the last 30 days or are currently participating in a clinical study. 13. Patients who are unlikely to comply with the requirements of the study protocol or who are at risk of moving or being lost to follow up. 14. Expected change in treatment of concomitant disease. 15. Patients with a history of recurrent ocular herpes and/or recurrent uveitis. 16. Inadequate lid closure. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy variable of the study is: Efficacy of Ialurex vs. Systane Eye Drops on the basis of: -Improvement of fluorescein corneal staining |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Systane TM Collirio Lubrificante |
|
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |